A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus

September 19, 2024 updated by: Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus in Patients With Ventricular Aneurysm and After Percutaneous Ventricular Reconstruction

The incidence of thrombosis in ventricular aneurysm was reported to be 35%-40%, which may lead to systemic thromboembolism. Patients with ventricular aneurysm without detectable thrombus are not routinely treated with anticoagulation. Therefore, the accuracy of intracardiac thrombus detection has an important impact on clinical management decisions. Currently, transthoracic echocardiography is the most commonly used method to detect intracardiac thrombus, but its sensitivity and positive predictive value are low. Cardiac magnetic resonance has a higher diagnostic accuracy for intracardiac thrombus, and its sensitivity and positive predictive value are higher than those of transthoracic echocardiography and CT. However, the gadolinium-based contrast agents commonly used for enhanced magnetic resonance imaging have some problems such as nephrogenic systemic fibrosis, gadolinium deposition in the brain, and short imaging time. Ferumoxytol, a superparamagnetic iron oxide nanoparticle, can be used for off-label enhanced magnetic resonance imaging. Its long intravascular half-life makes it suitable for enhanced magnetic resonance imaging with complex scanning procedures and long repetitive scans. Ferumoxytol is cleared from the blood pool by macrophages of the reticuloendothelial system, mainly in the spleen and lymph nodes. Therefore, ferumoxytol has a favourable safety even in adults and children with end-stage renal failure. The aim of this study is to evaluate the effectiveness of a novel ferumoxytol-enhanced cardiac magnetic resonance in detecting intracardiac thrombus in patients with ventricular aneurysm and after percutaneous ventricular reconstruction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Ferumoxytol is a member of ultrasmall superparamagnetic iron oxide particles with an average diameter of 30 nm, originally developed as an intravascular contrast agent for MRI. Ferumoxytol was approved by the FDA in 2009 for the intravenous treatment of iron deficiency anaemia in adults with chronic kidney disease, and has also been used off-label as a non-gadolinium contrast agent for whole-body magnetic resonance imaging. Its iron oxide core is coated with dextran, which reduces immunogenicity and delays phagocytosis and the release of elemental iron from the core. As a result, ferumoxytol has a long intravascular half-life of approximately 15 hours and is slowly taken up by the macrophages of the reticuloendothelial system. Because of its long half-life, ferumoxytol is suitable for enhanced magnetic resonance imaging with complex scanning procedures and long repetitive scans. Ferumoxytol has been proved to be safe even in adults and children with end-stage renal failure. As feraheme is not available in the Chinese market, we experimentally synthesised a new formulation of ferumoxytol, which is identical to ferumoxytol in terms of physicochemical structure, pharmacokinetics and toxicological effects, at the request of Chia Tai Tianqing Pharmaceutical Group Co, Ltd (Nanjing, China) in 2014. This study is a single-centre, prospective, observational, non-randomised study. The study will enrol patients with ventricular aneurysm and after percutaneous ventricular reconstruction. The aim of this study is to evaluate the effectiveness of ferumoxytol-enhanced cardiac magnetic resonance imaging in detecting intracardiac thrombus in patients with ventricular aneurysm and left ventricular thrombus in the dynamic chamber and static chamber in patients 180±30 days after percutaneous ventricular reconstruction by comparing the detection rate of intracardiac thrombus with ferumoxytol-enhanced cardiac magnetic resonance imaging and transthoracic echocardiography, and to provide a clinical basis for the development and application of the new generation of magnetic resonance contrast agents in China. The echocardiography and magnetic resonance imaging experts were blinded to each other's results.

Study Type

Observational

Enrollment (Estimated)

320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

300 patients with ventricular aneurysm and 10 to 20 patients after percutaneous ventricular reconstruction at the First Affiliated Hospital of Nanjing Medical University

Description

Inclusion criteria:

  1. Age ≥ 18 years and ≤ 80 years;
  2. Patients with left ventricular aneurysm detected by transthoracic echocardiography or 180±30 days after percutaneous ventricular reconstruction;
  3. An informed consent form was signed voluntarily by the patients or an authorised family member.

Exclusion criteria:

  1. Patients unable to lie down for any reason;
  2. Patients who are unable to undergo MRI for psychological (e.g. suffering from claustrophobia syndrome) or physical reasons (e.g. non-antimagnetic metal retention in the body, hearing impairment, involuntary body movements, etc.);
  3. Patients with a known history of iron allergy or hypersensitivity;
  4. Patients taking other oral or intravenous iron products;
  5. Patients with haemosiderin deposition or haemochromatosis;
  6. Pregnant or lactating women;
  7. Any other patient that the investigator deems inappropriate for enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with ventricular aneurysm and after percutaneous ventricular reconstruction
Patients with ventricular aneurysm and after percutaneous ventricular reconstruction undergo a novel ferumoxytol-enhanced cardiac magnetic resonance imaging and transthoracic echocardiography.
Drug: Superparamagnetic Iron Oxide Nanoparticles
Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.
Other Names:
  • ferumoxytol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection rate of intracardiac thrombus
Time Frame: Nov. 1st, 2023 to Mar. 31st, 2025
Detection rate of intracardiac thrombus by ferumoxytol-enhanced magnetic resonance and transthoracic echocardiography
Nov. 1st, 2023 to Mar. 31st, 2025
detection rate of thrombus in dynamic chamber and static chamber
Time Frame: Nov. 1st, 2023 to Mar. 31st, 2025
Detection rate of thrombus in dynamic chamber and static chamber by ferumoxytol-enhanced magnetic resonance and transthoracic echocardiography in patients after percutaneous ventricular reconstruction
Nov. 1st, 2023 to Mar. 31st, 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • Principal Investigator: Chunjian Li, MD, PhD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

November 18, 2023

First Submitted That Met QC Criteria

November 18, 2023

First Posted (Actual)

November 27, 2023

Study Record Updates

Last Update Posted (Actual)

September 23, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Aneurysm

Clinical Trials on Superparamagnetic Iron Oxide Nanoparticles

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Madagascar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe